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GAO-01-1011 Attention Disorder Drugs: Few Incidents of Diversion

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GAO-01-1011 Attention Disorder Drugs: Few Incidents of Diversion United States General Accounting Office GAO Report to Congressional Requesters September 2001 ATTENTION DISORDER DRUGS Few Incidents of Diversion or Abuse Identified by Schools GAO-01-1011 Contents Letter 1 Results in Brief 2 Background 2 Few Incidents of Diversion or Abuse of Attention Disorder Drugs Identified by Schools 6 Most Schools Dispense Attention Disorder Medications and Follow Drug Security Procedures 10 Many States and Local School Districts Have Provisions for School Administration of Medications 15 Conclusions 19 Agency Comments 20 Appendix I Objectives, Scope and Methodology 21 Appendix II Survey of Public School Principals – Diversion/Abuse of Medication for Attention Disorders 26 Appendix III State Controls on Dispensing of Drugs in Public Schools 33 Appendix IV Anecdotal Accounts of School-Based Diversion or Abuse of Attention Disorder Medications 36 Appendix V Studies Related to Diversion or Abuse of Methylphenidate by School-Aged Children 38 Appendix VI State Statutes, Regulations, and Mandatory Policies Addressing the Administration of Medication to Students 40 Page i GAO-01-1011 Attention Disorder Drugs Appendix VII GAO Contacts and Staff Acknowledgments 46 Tables Table 1:Rise in Production Quota for Methylphenidate and Amphetamine 5 Table 2:Measures Taken by School Officials as a Consequence of Diversion or Abuse of Attention Disorder Drugs 9 Table 3: School Personnel Dispensing Attention Disorder Medication 13 Table 4: Sample of Schools in Our Study 23 Figures Figure 1: Brand Name Methylphenidate Pills 4 Figure 2: Percent of Middle and High Schools Identifying Diversion or Abuse of Attention Disorder Drugs in the 2000–2001 School Year 7 Figure 3: Diversion or Abuse of Attention Disorder Drugs at Middle and High Schools and by Community Type 8 Figure 4: Percent of Schools Where School Staff Administer Medication by Middle and High Schools and by Community Type 11 Figure 5: Number of Attention Disorder Pills Typically on Hand for Dispensing at School 12 Figure 6: Storage of ADHD and Other Medications 14 Abbreviations ADHD Attention Deficit Hyperactivity Disorder CCD Common Core of Data DEA Drug Enforcement Administration FDA Food and Drug Administration Page ii GAO-01-1011 Attention Disorder Drugs United States General Accounting Office Washington, DC 20548 September 14, 2001 The Honorable F. James Sensenbrenner Chairman The Honorable Henry Hyde Committee on the Judiciary House of Representatives Children diagnosed with attention deficit disorders are commonly treated with stimulant medications, such as Ritalin or Adderall. These drugs are controlled substances under federal law because of their high abuse potential. Many of these stimulant drugs must be taken several times a day to be effective, so that children need medication during the school day. There is some concern that the increase in the use of these medications in a school environment might provide additional opportunities for the diversion or abuse of these drugs. There is no data on the extent to which attention disorder drugs have been diverted or abused at school, or the extent to which state laws or regulations guide local school officials in safely administering these drugs. To clarify these issues, you asked us to provide you with information and analysis on (1) the diversion and abuse of attention deficit disorder drugs in public schools,1 (2) the school environment in which drugs are administered to students, and (3) the state laws or regulations addressing the administration of prescription drugs in schools. To address the first two objectives, we surveyed principals from a representative national sample of public middle schools and high schools. Elementary schools were not included based on discussion with your staff. For the third objective, we surveyed state Department of Education officials (or their designees) in the 50 states and the District of Columbia. Specific information on our objectives, scope, and methodology is provided in appendix I, and copies of our survey instruments are presented in appendixes II and III. 1 For this report, “diversion or abuse” includes any instances in which the drug was stolen, illegally sold, given away, or traded; possessed or ingested without a prescription; or otherwise involved outside of sanctioned uses. Page 1 GAO-01-1011 Attention Disorder Drugs Middle and high school principals we surveyed reported little diversion or Results in Brief abuse of attention disorder drugs. For the first 7 to 9 months of school year 2000-2001, approximately 8 percent of principals in public middle and high schools reported knowing of attention disorder drugs being diverted or abused at their school. Most of those principals reported knowing of only one incident. Approximately 89 percent of the principals reported that at their school, the diversion or abuse of attention disorder drugs was less of a problem than other illicit drugs (excluding problems with alcohol and marijuana). We were unable to draw any statistical conclusions about associations between the reporting of incidents and other school characteristics, such as if it was a middle or high school, due to the low number of incidents overall. Most of the principals reported that school officials administer attention disorder medications, with about 2 percent of the school’s students on average being administered attention disorder drugs on a typical day. Medications are administered by nurses in about 60 percent of the schools, and by non-health professionals, such as secretaries in most of the remaining schools. Medications are kept locked in almost all (96 percent) of the schools according to the principals, and students are observed while taking their medications. We could not draw any statistical conclusions relating incidents to who administers the medications, the number of children on attention disorder medications, variations in storage, or medication transportation due to the low number of incidents overall. Thirty-seven states and the District of Columbia have either statutes, regulations, and/or mandatory policies addressing the administration of medication to students, based on our survey of state Department of Education officials. State provisions include, for example, that schools obtain written parental authorization to administer medication, ensure that the medication is securely stored, and require prescription medication to be stored in the original pharmacy container. Almost 90 percent of principals reported their school received state and/or local guidance regarding the administration of medications. Attention deficit disorders are among the most commonly diagnosed Background childhood behavioral disorders. Although there are a number of disorder subtypes, as a group these disorders are referred to as Attention Deficit Hyperactivity Disorder (ADHD). Symptoms include hyperactivity, impulsiveness, and inattention. The American Psychiatric Association’s Page 2 GAO-01-1011 Attention Disorder Drugs diagnostic manual2 provides criteria for identifying ADHD; however, there is no agreed upon test to confirm an attention disorder. Estimates of the prevalence of the disorder vary widely. A recent international review of 19 epidemiological studies conducted in various countries since 1980 on the prevalence of ADHD in school-age children reported ranges of 2 percent to 18 percent. The review found that the ADHD prevalence rate varies depending on the diagnostic criteria, the children included in the sample, and how the data were collected. Researchers conducting the review concluded with a “best” estimate of between 5 and 10 percent of children and adolescents having some form of this disorder.3 Although controversial, stimulants are the most common treatment for attention disorder symptoms and are the only drugs that are approved by the Food and Drug Administration (FDA) for this purpose. Methylphenidate is the most widely used stimulant, but amphetamines have been increasingly prescribed. Antidepressants, including buproprion and velafaxine, are not approved by the FDA for the treatment of ADHD; however, they are sometimes prescribed by physicians for ADHD if stimulant medications are ineffective or inappropriate for a particular patient. ADHD drugs come in generic forms, but are often referred to by their brand names. Methylphenidate brand names include Ritalin (see fig. 1), Concerta, Methylin and Metadate. Brand name amphetamines include Adderall, Dexedrine, and Dextrostat. Both types of stimulants are available in quick acting, but short duration (2 to 6 hours) tablets. Recently, sustained or extended release tablets lasting 8 to 12 hours have become available, and a once-a-day skin patch is under development. Longer acting drugs may reduce the need for some children to take their medications at school. Several companies are testing nonstimulant drugs for ADHD treatment that do not have the potential for abuse or physical dependency associated with stimulant drugs.4 2 Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR, 4th edition, 2000. Diagnosis consists of a combination of symptoms, such as “often does not seem to listen when spoken to directly,” or “often fidgets with hands or feet or squirms in seat.” 3 Larry Scahill, MSN, PhD and Mary Schwab-Stone, MD, Epidemiology of ADHD in School- Age Children, Child and Adolescent Psychiatric Clinics of North America, Vol. 9(3), (July 2000). 4 Nonstimulant drugs under development and their manufacturers include Atomoxetine (Lilly), GW 320659 (GlaxoSmith Kline), Perceptin (Gilatech).
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